Jena, 27. April. 2007 – biolitec AG wants to significantly accelerate the launch of Foscan® in the USA. Based on the Foscan® confirmatory study biolitec requested an immediate approvability meeting with the FDA. “The meeting with the FDA on an immediate US approval for Foscan® shall take place in early July”, explains Dr. Wolfgang Neuberger, CEO of biolitec AG.

The specific objective of this meeting is to reach agreement with US Food and Drug-Administration on the acceptability of biolitec’s proposal for a NDA (New Drug Application) supplemental submission based on the results of the currently completed confirmatory study. The results of the confirmatory study are outstanding. The latest confirmatory study states a considerable efficacy of Foscan® exceeding the results from the earlier (8b) study. The meeting shall centre on the safety and effectiveness of Foscan® for the treatment of recurrent squamous cell cancer of the head and neck in pa-tients who failed prior therapies and were unsuitable to receive other thera-pies.

With an US approval for Foscan® biolitec could serve the world’s largest market for this innovative treatment. In the USA 108,000 late head and neck cancers and 55,000 early head and neck cancers receive a total of 233,000 treatments per year.

Cancer is the second most common cause of death in the developed countries. Annually worldwide more than 11 million people are diagnosed with cancer. Until 2020 experts expect an increase to over 16 million people. The market for cancer medicine is valued at a total volume of 60 billion U.S. dollars up to the year 2010.

"The USA are the most important market for biolitec AG. With expected expenditures for cancer therapies amounting to 16.8 billion U.S. dollars, very good sales opportunities arise for Foscan ® in the case of a FDA approval", explains Dr. Neuberger.

In case of FDA approval, biolitec will make the appropriate milestone payment agreed when the drug patents were purchased out of its free cash. biolitec expects a considerable turnover potential in the US, where innovative, approved drugs are more readily reimbursed than in Europe.

The parallel ongoing negotiations with U.S. companies about an out licensing of Foscan® let expect further market potential. “biolitec already benefits from the enhanced visibility in the US investment community as well as in the US financial market. This has positive effect on interested new shareholders and the sale of biolitec’s other product lines”, Dr. Neuberger adds.

About biolitec AG:

biolitec is the only supplier for photodynamic therapy worldwide that offers all relevant core competencies – photosensitizers, lasers and optical fibres. Apart from the dermatology, tumours and dysplasias business units, biolitec AG has also successfully developed competencies in the fields of ophthalmology, dentology and cosmetics. With the photodynamic drug Foscan® biolitec AG possesses an approved therapeutic drug for the EU. biolitec is listed in Prime Standard of the Frankfurt Stock Exchange market (ISIN DE0005213409).